Ophthalmology Times Juli 2019

Testo completo

(1)CUT TING - EDGE ADVANCEMENT S CLINICAL DIAGNOSIS. OphthalmologyTimes.com Surgery. VALUING MACULAR OCT FOR PREOP CATARACT SURGERY EVALUATION. SURGERY. July 15, 2019 VOL. 44, NO. 12. DRUG THERAPY. Device renews hope for artificial vision Visual cortical prosthesis intended to create artificial form of useful vision for blind individuals In View. THOUGH THE DILATED clinical fundus examination is considered the standard of care for preoperative evaluation of the macula, its limited ability to detect pathology in patients with opaque media is a specific concern in the setting of patients presenting for cataract surgery, explains Yishay Weill, MD. “Preoperative OCT allows better patient management in terms of guiding appropriate surgery planning, timing, and planning, modification of consent, patient counseling, and matching patient expectations,” Dr. Weill said.. THE VISUAL CORTICAL PROSTHESIS SYSTEM is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. p (Images courtesy of Second Sight Medical Products Inc.). Continues on page 10 : Macular OCT. Clinical Diagnosis. EXPLORING NOCTURNAL EVAPORATIVE STRESS IN DRY EYE PATIENTS OPHTHALMOLOGISTS frequently educate their patients on the role of sleep as a facilitator of overall good health. But, what happens when diligent sleepers wake with dry eye symptoms that are decidedly worse, not better? The strange phenomena of her patients getting more and better sleep—and still waking up with peak severity dry eye symptoms— led Laura M. Periman, MD, to investigate the cause of, and potential remedies for, symptomatic dry eye that worsens overnight. Nocturnal evaporative stress is a frequently overlooked and undermanaged component of dry eye care. Dr. Periman shares some tips for a more proactive approach to identifying and managing these cases.. Continues on page 36 : Nocturnal. By Lynda Charters; Reviewed by Nader Pouratian, MD, PhD A NOVEL visual cortical prosthesis system (Orion, Second Sight Medical Products) is expanding the pool of patients who can benefit from artificial vision. Patients include not only those with retinal disease—such as retinitis pigmentosa, diabetic retinopathy, and glaucoma—but also those who have lost vision to eye injury or optic nerve injury/ disease and are ineligible for any other visual prosthetic. The FDA recently approved the system for an Early Feasibility Study through its Breakthrough Device pathway—and the latest results at 12 months have been positive, said Nader Pouratian, MD, PhD,. one of the study’s principal investigators. “We need to realize that the goal of a system, such as [this], is not to restore vision as we know it in sighted individuals, but to restore visual perception to blind people to allow better function in and interaction with the world,” said Dr. Pouratian, associate professor of neurosurgery, Ronald Reagan UCLA Medical Center, Santa Monica, CA. “In achieving that goal, we are making huge progress.” The visual cortical prosthesis system is designed to bypass the eyes and optic nerve, i.e., the diseased or injured tissue. Patients wear a miniature camera mounted on a pair of eyeglasses, an antenna, and a video processing unit (VPU). The camera captures real-time images as processed by the VPU and then converted into stimulation patterns that are transmitted wirelessly to an electrode array implanted on the surface of. the primary visual cortex. The system has 60 elect electrical contacts that deliver the stimulat stimulation to the brain, he noted. feasib The feasibility study is being conducted by Dr Dr. Pouratian; Jessy D. Dorn, PhD, senior director of scientific research, Second Sight Medical Products; Robert Greenberg, MD, PhD, at UCLA, and at Baylor College of Medicine, Houston, where Daniel Yoshor, MD, is site director and also one of the principal investigators. Six subjects (five men, 1 woman; age range, 29-57 years), who became blind from disease or injury and had a normal visual cortex, participated and will be followed for 5 years. Specifically, three patients suffered a trauma, two had glaucoma, and one had endophthalmitis. To now, the average time after implantation is about 12 months. During the first testing of the device after implantation, 2 weeks postoperatively, each electrical contact is turned on individually to determine at what level of stimulation results in a visual perception, i.e., phosphenes. Continues on page 13 : Cortical prosthesis. HOSPITAL CLOSURES HURT Impact far-reaching for patients, residency training slots for future ophthalmologists.

(2) Less stress, pure success 1 ...in your O.R. day. ™. References: 1. Omeros survey data on file. 2. Silverstein SM, Rana V, Stephens R, Segars L, Pankratz J, Shivani R, et al. Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy-iris syndrome. J Cataract Refract Surg. 2018;44(9):1103-1108. 3. Rosenberg ED, Nattis AS, Alevi D, et al. Visual outcomes, efficacy, and surgical complications associated with intracameral phenylephrine 1.0%/ketorolac 0.3% administered during cataract surgery. Clin Ophthalmol. 2018;12:21-28. 4. Bucci FA Jr, Michalek B, Fluet AT. Comparison of the frequency of use of a pupil expansion device with and without an intracameral phenylephrine and ketorolac injection 1%/0.3% at the time of routine cataract surgery. Clin Ophthalmol. 2017;11:1039-1043. 5. Visco D. Effect of phenylephrine/ketorolac on iris fixation ring use and surgical times in patients at risk of intraoperative miosis. Clin Ophthalmol. 2018;12:301-305. 6. Walter K, Delwadia N. Miosis prevention in femtosecond cataract surgery using a continuous infusion of phenylephrine and ketorolac. Presented at: 2018 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting; April 13-17, 2018; Washington, DC. 7. Matossian C. Clinical outcomes of phenylephrine/ketorolac vs. epinephrine in cataract surgery in a real-world setting. Presented at: American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting; April 13-17, 2018; Washington, DC. 8. Al-Hashimi S, Donaldson K, Davidson R, et al. Medical and surgical management of the small pupil during cataract surgery. J Cataract Refract Surg. 2018;44:1032-1041. 9. Gayton JL. E-poster presented at: 15th International Congress on Vision Science and Eye; 2017 Aug 10-11; London, UK. 10. Katsev DA, Katsev CC, Pinnow J, Lockhart CM. Intracameral ketorolac concentration at the beginning and end of cataract surgery following preoperative topical ketorolac administration. Clin Ophthalmol. 2017;11:1897-1901. 11. Waterbury LD. Alternative drug delivery for patients undergoing cataract surgery as demonstrated in a canine model. J Ocul Pharmacol Ther. 2018;34:154-160. 12. Visco D. et al. Study to evaluate patient outcomes following cataract surgery when using OMIDRIA with postoperative topical NSAID administration versus a standard regimen of postoperative topical NSAIDs and steroids. Presented at: 28th Annual Meeting of the American College of Eye Surgeons (ACES), the American Board of Eye Surgery (ABES), and the Society for Excellence in Eyecare (SEE), Caribbean Eye Meeting; February 1-5, 2019; Cancún, Mexico. 13. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2017..

(3) OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is added to ophthalmic irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.. The data are compelling and consistent—OMIDRIA makes cataract surgery better for you and your patients Published and presented clinical studies and manuscripts in press and/or in preparation report that in post-launch (i.e., not included in current labeling), prospective and retrospective, doublemasked and open-label, cohort and case-controlled, single- and multi-center analyses, the use of OMIDRIA, compared to the surgeons’ standard of care, statistically significantly: Prevents Intraoperative Floppy Iris Syndrome (IFIS)2 Reduces complication rates (epinephrine comparator)3 Decreases use of pupil-expanding devices (epinephrine comparator)3-8 Reduces surgical times (epinephrine comparator)3,5,7,8 Prevents miosis during femtosecond laser-assisted surgery (epinephrine comparator)6,9 Improves uncorrected visual acuity on day after surgery (epinephrine comparator)3 Delivers NSAID to the anterior chamber and related structures better than routine preoperative topical drug administration, resulting in effectively complete postoperative inhibition of COX-1 and COX-210,11 • Reduces the incidence of rebound iritis, postoperative pain/photophobia, and cystoid macular edema (CME) in patients without preoperative vitreomacular traction (VMT), when used with a postoperative topical NSAID (compared to postoperative topical NSAID + corticosteroid without OMIDRIA)12 • • • • • • •. OMIDRIA inhibits prostaglandin release, reducing intraoperative inflammation, to prevent miosis and reduce postoperative pain13 OMIDRIA is separately reimbursed under Medicare Part B and by many Medicare Advantage and commercial payers.* Contact your OMIDRIA representative today or visit omidria.com to learn more.. *Based on currently available information and subject to change without notice. Individual plan coverage, policies, and procedures may vary and should be confirmed. Omeros does not guarantee coverage or payment.. IMPORTANT SAFETY INFORMATION OMIDRIA must be added to irrigating solution prior to intraocular use. OMIDRIA is contraindicated in patients with a known hypersensitivity to any of its ingredients. Systemic exposure of phenylephrine may cause elevations in blood pressure. Use OMIDRIA with caution in individuals who have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory drugs (NSAIDs), or have a past medical history of asthma. The most commonly reported adverse reactions at ≥2% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Please see the Full Prescribing Information for OMIDRIA at www.omidria.com/prescribinginformation. You are encouraged to report Suspected Adverse Reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. OMIDRIA® and the OMIDRIA logo® are registered trademarks of Omeros Corporation. © Omeros Corporation 2019, all rights reserved. 2019-005.

(4) 4. JULY 15, 2019 :: Ophthalmology Times. contents 14 10 37 Surgery. Drug Therapy. Clinical Diagnosis. 18 CONSIDER HYPOTONY SYMPTOMS DURING THERAPY. 33 STUDY LINKS LONG-TERM STATIN USE WITH LOWER POAG RISK. 36 EXPLORING DRY EYE SYMPTOMS THAT WORSEN DURING NIGHT. Though numerous techniques are available to surgeons, awareness is important.. In This Issue. 6 EDITORIAL. What’s Trending See what the ophthalmic community is reading on OphthalmologyTimes.com. Here’s why IPL 1 PODCAST: is a practice game changer http://bit.ly/2JOjrsG. Patients who used statins for five years or more had reduced chance of glaucoma.. Poor eyelid performance while sleeping may be common contributing factor.. 34 MARKETPLACE. Digital App. Video. Introducing the Ophthalmology Times app for iPad and iPhone. Download it for free today at OphthalmologyTimes. com/OTapp.. NES in dry eye 2 Investigate patients http://bit.ly/2LfVb5A. burnout: 3 Physician Truth or myth? http://bit.ly/2XY3TaT. and OCTA: Seeing deeper 4 OCT into sickle cell retinopathy http://bit.ly/2xTKq0d. eNewsletter Sign up for Ophthalmology Times’ weekly newsletter at https://bit.ly/ 2OqBJ56.. Robert Maloney, MD, discusses how a novel system can better assist refractive surgeons. Go to http://bit.ly/2Gk4flU. Facebook Like Ophthalmology Times at Facebook.com/OphthalmologyTimes.

(5) THE RIGHT ROUTE CAN MAKE ALL THE DIFFERENCE. Access retinal disease directly through the suprachoroidal space. The suprachoroidal space provides a novel approach XSHVYKHIPMZIV]SǺIVMRKRI[STTSVXYRMXMIWXSEGGIWW diseased tissue in the back of the eye.1. See the potential at SuprachoroidalSpace.com.

(6) 6. editorial. JULY 15, 2019 :: Ophthalmology Times. THE CYCLE OF INFLAMMATION IN DRY EYE DISEASE2. Hospital closures hurt Impact far-reaching from patients to residency training By Peter J. McDonnell, MD director of the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, and chief medical editor of Ophthalmology Times. He can be reached at 727 Maumenee Building 600 N. Wolfe St. Baltimore, MD 21287-9278 Phone: 443/287-1511 Fax: 443/287-1514 E-mail: [email protected]. THE MORNING newspaper reports the bankruptcy of a large inner-city hospital in Philadelphia. Hahnemann Hospital—which has 496 beds and treats 56,000 patients a year in its emergency room—announced it had liabilities in the range of $100-$500 million and assets in the range of $10-$50 million (in other words, it is a financial disaster). News reports state that the hospital has stopped accepting trauma patients despite statements from government regulators that this was not acceptable. One report says the state has issued an order for the hospital to “cease and desist” its closure plans. Along with court battles is the weighing in of one presidential candidate, Sen. Bernie Sanders (D-VT), who calls closure of the hospital “insane.” While I have no information about this confused state of events beyond that published in the media, my belief is that events like this are likely to occur from time to time—possibly with increasing frequency—in coming years. Many academic medical centers located within inner cities are meeting important healthcare needs of a community in which poor nutrition, obesity, drug use, limited education, chronic medical illnesses, and poverty are becoming increasingly common. As regulatory requirements (think electronic medical records, compliance programs, etc.) and increasing costs overall drive up expenses, our society is increasingly unwilling to write larger and larger checks to cover the costs for those who are uninsured or underinsured. CHANGING TIMES I suppose fans of Darwin would say that this type of process is necessary to winnow out those institutions that cannot adapt to the changing realities of our healthcare system. Increasingly, for teaching hospitals in urban areas, the game is to provide excellent high-level care for complicated problems in order to attract. complicated patients with good insurance who will travel to access this high-quality care. Payments received for the care of these complicated patients can then be used to subsidize the care provided to local patients with “bread-andbutter” medical issues and whose insurance does not come close to covering the cost of care (Medicaid) or who have no insurance at all and lack the means to pay. My reference to teaching in the paragraph above highlights one bit of collateral damage in this drama—the ophthalmology residency program in this hospital is being shut down. Though I don’t know a great deal about this particular residency program, it is clear that inner-city hospitals provide fertile ground for residents eager to learn by helping patients. Preventing or reducing vision loss from diabetic retinopathy and glaucoma—two common diseases that disproportionately impact these communities—allow residents to have a positive impact. The ocular trauma that is unfortunately too common in our large cities provide residents an important experience. And few things are more delightful to an ophthalmologist-in-training than restoring the sight of a person with a severe cataract who cannot afford to pay anything. It will be stressful for the ophthalmology residents (as well as those in other specialties) if they must relocate to different programs in different cities, but in the past such residents have been assured of the ability to complete their training. It is not good for our profession or the American public, however, if the number of training slots in ophthalmology is allowed to decrease. With the continued growth in the U.S. population, combined with the demographic tidal wave of senior citizens, this is not a good time for us to reduce the number of future ophthalmologists. ■. Ocular Surface Stress. +PƃCOOCVKQP. 6GCT(KNO+PUVCDKNKV[. 5KIPU5[ORVQOU REFERENCE • https://philadelphia.cbslocal.com/2019/07/14/presidentialcandidate-bernie-sanders-hahnemann-university-hospitalclosure/.

(7) XIIDRA MAY INTERRUPT THE CYCLE OF INFLAMMATION CENTRAL TO DRY EYE DISEASE1,2 The exact mechanism of action of Xiidra in Dry Eye Disease is not known.1. Xiidra blocks the interaction of ICAM-1 and LFA-1, which is a key OGFKCVQTQHVJGKPƃCOOCVKQP central to Dry Eye Disease. In vitro studies have shown that Xiidra may inhibit the recruitment of previously activated T cells, the activation of newly recruited T cells, and VJGTGNGCUGQHRTQKPƃCOOCVQT[ cytokines.1. Check out Xiidra-ECP.com. Indication Xiidra® NKƂVGITCUVQRJVJCNOKEUQNWVKQP KUKPFKECVGFHQTVJG VTGCVOGPVQHUKIPUCPFU[ORVQOUQHFT[G[GFKUGCUG &'& Important Safety Information :KKFTCKUEQPVTCKPFKECVGFKPRCVKGPVUYKVJMPQYPJ[RGTUGPUKVKXKV[ VQNKƂ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ƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJGCIGQH[GCTU JCXGPQVDGGPGUVCDNKUJGF. For additional safety information, see accompanying Brief Summary of Safety Information on the adjacent page and Full Prescribing Information on Xiidra-ECP.com. References: 1. :KKFTC=2TGUETKDKPI+PHQTOCVKQP?.GZKPIVQP/#5JKTG75 2. 6(15&'95++4GUGCTEJ5WDEQOOKVVGG4GRQTVQHVJG4GUGCTEJ5WDEQOOKVVGG QHVJG6GCT(KNO1EWNCT5WTHCEG5QEKGV[&T['[G9QTM5JQR++ Ocul Surf ©2018 Shire US Inc., Lexington, MA 02421. 1-800-828-2088. All rights reserved. SHIRE and the Shire Logo >ÀiÌÀ>ì>ÀÃÀÀi}ÃÌiÀi`ÌÀ>ì>ÀÃv-Ài*>À>ViÕÌV>` }ÃÀi> `Ìi`ÀÌÃ>vw>ÌiÃ° Marks designated ® > `Ò>ÀiÜ i`LÞ- ÀiÀ>>vw>Ìi`V«>Þ°-{ä{{näÇÉ£n.

(8) Rx Only. BRIEF SUMMARY: Consult the Full Prescribing Information for complete product information. INDICATIONS AND USAGE Xiidra® NKƂVGITCUVQRJVJCNOKEUQNWVKQP KUKPFKECVGFHQTVJG VTGCVOGPVQHVJGUKIPUCPFU[ORVQOUQHFT[G[GFKUGCUG &'& DOSAGE AND ADMINISTRATION Instill one drop of Xiidra twice daily (approximately 12 hours CRCTV KPVQGCEJG[GWUKPICUKPINGWUGEQPVCKPGT&KUECTF VJGUKPINGWUGEQPVCKPGTKOOGFKCVGN[CHVGTWUKPIKPGCEJG[G Contact lenses should be removed prior to the administration QH:KKFTCCPFOC[DGTGKPUGTVGFOKPWVGUHQNNQYKPI administration. CONTRAINDICATIONS Xiidra is contraindicated in patients with known hypersensitivity VQNKƂVGITCUVQTVQCP[QHVJGQVJGTKPITGFKGPVUKPVJG formulation. ADVERSE REACTIONS Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical VTKCNUQHCPQVJGTFTWICPFOC[PQVTGƃGEVVJGTCVGUQDUGTXGF KPRTCEVKEG+PƂXGENKPKECNUVWFKGUQHFT[G[GFKUGCUGEQPFWEVGF YKVJNKƂVGITCUVQRJVJCNOKEUQNWVKQPRCVKGPVUTGEGKXGFCV NGCUVFQUGQHNKƂVGITCUV QHYJKEJTGEGKXGFNKƂVGITCUV 6JGOCLQTKV[QHRCVKGPVU JCFŰOQPVJUQHVTGCVOGPV GZRQUWTGRCVKGPVUYGTGGZRQUGFVQNKƂVGITCUVHQT approximately 12 months. The majority of the treated patients YGTGHGOCNG 6JGOQUVEQOOQPCFXGTUGTGCEVKQPU TGRQTVGFKPQHRCVKGPVUYGTGKPUVKNNCVKQPUKVGKTTKVCVKQP dysgeusia and reduced visual acuity. Other adverse reactions TGRQTVGFKPVQQHVJGRCVKGPVUYGTGDNWTTGFXKUKQP conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis. Postmarketing Experience 6JGHQNNQYKPICFXGTUGTGCEVKQPUJCXGDGGPKFGPVKƂGFFWTKPI postapproval use of Xiidra. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Rare cases of hypersensitivity, including anaphylactic reaction, bronchospasm, respiratory distress, pharyngeal edema, swollen tongue, and urticaria have been reported. Eye swelling and rash have been reported. USE IN SPECIFIC POPULATIONS Pregnancy There are no available data on Xiidra use in pregnant women to KPHQTOCP[FTWICUUQEKCVGFTKUMU+PVTCXGPQWU +8 CFOKPKUVTCVKQP QHNKƂVGITCUVVQRTGIPCPVTCVUHTQORTGOCVKPIVJTQWIJ IGUVCVKQPFC[FKFPQVRTQFWEGVGTCVQIGPKEKV[CVENKPKECNN[ relevant systemic exposures. Intravenous administration of NKƂVGITCUVVQRTGIPCPVTCDDKVUFWTKPIQTICPQIGPGUKURTQFWEGF an increased incidence of omphalocele at the lowest dose. VGUVGFOIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCV the recommended human ophthalmic dose [RHOD], based on VJGCTGCWPFGTVJGEWTXG=#7%?NGXGN 5KPEGJWOCPU[UVGOKE GZRQUWTGVQNKƂVGITCUVHQNNQYKPIQEWNCTCFOKPKUVTCVKQPQH:KKFTC CVVJG4*1&KUNQYVJGCRRNKECDKNKV[QHCPKOCNƂPFKPIUVQVJG risk of Xiidra use in humans during pregnancy is unclear. Animal Data .KƂVGITCUVCFOKPKUVGTGFFCKN[D[KPVTCXGPQWU +8 KPLGEVKQP VQTCVUHTQORTGOCVKPIVJTQWIJIGUVCVKQPFC[ECWUGF an increase in mean preimplantation loss and an increased KPEKFGPEGQHUGXGTCNOKPQTUMGNGVCNCPQOCNKGUCVOIMI FC[TGRTGUGPVKPIHQNFVJGJWOCPRNCUOCGZRQUWTGCV the RHOD of Xiidra, based on AUC. No teratogenicity was QDUGTXGFKPVJGTCVCVOIMIFC[ HQNFVJGJWOCP RNCUOCGZRQUWTGCVVJG4*1&DCUGFQP#7% +PVJGTCDDKV an increased incidence of omphalocele was observed at the NQYGUVFQUGVGUVGFOIMIFC[ HQNFVJGJWOCPRNCUOC GZRQUWTGCVVJG4*1&DCUGFQP#7% YJGPCFOKPKUVGTGFD[ +8KPLGEVKQPFCKN[HTQOIGUVCVKQPFC[UVJTQWIJ#HGVCN0Q 1DUGTXGF#FXGTUG'HHGEV.GXGN 01#'. YCUPQVKFGPVKƂGFKP the rabbit. Lactation 6JGTGCTGPQFCVCQPVJGRTGUGPEGQHNKƂVGITCUVKPJWOCP milk, the effects on the breastfed infant, or the effects on milk RTQFWEVKQP*QYGXGTU[UVGOKEGZRQUWTGVQNKƂVGITCUVHTQO ocular administration is low. The developmental and health DGPGƂVUQHDTGCUVHGGFKPIUJQWNFDGEQPUKFGTGFCNQPIYKVJ the mother’s clinical need for Xiidra and any potential adverse effects on the breastfed child from Xiidra. Pediatric Use 5CHGV[CPFGHƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJGCIGQH years have not been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Animal studies have not been conducted VQFGVGTOKPGVJGECTEKPQIGPKERQVGPVKCNQHNKƂVGITCUV Mutagenesis: .KƂVGITCUVYCUPQVOWVCIGPKEKPVJGin vitro #OGUCUUC[.KƂVGITCUVYCUPQVENCUVQIGPKEKPVJGin vivo mouse micronucleus assay. In an in vitro chromosomal aberration assay using mammalian cells (Chinese JCOUVGTQXCT[EGNNU NKƂVGITCUVYCURQUKVKXGCVVJGJKIJGUV concentration tested, without metabolic activation. Impairment of fertility: .KƂVGITCUVCFOKPKUVGTGFCV KPVTCXGPQWU +8 FQUGUQHWRVQOIMIFC[. HQNFVJGJWOCPRNCUOCGZRQUWTGCVVJG TGEQOOGPFGFJWOCPQRJVJCNOKEFQUG 4*1& QH NKƂVGITCUVQRJVJCNOKEUQNWVKQP JCFPQGHHGEVQP fertility and reproductive performance in male and female treated rats.. /CPWHCEVWTGFHQT5JKTG75+PE5JKTG9C[.GZKPIVQP/# (QTOQTGKPHQTOCVKQPIQVQYYY:KKFTCEQOQTECNN Marks designated ®CPFvCTGQYPGFD[5JKTGQTCPCHƂNKCVGFEQORCP[ 5JKTG75+PE5*+4'CPFVJG5JKTG.QIQCTGVTCFGOCTMUQT TGIKUVGTGFVTCFGOCTMUQH5JKTG2JCTOCEGWVKECN*QNFKPIU+TGNCPF .KOKVGFQTKVUCHƂNKCVGU Patented: please see JVVRUYYYUJKTGEQONGICNPQVKEGRTQFWEVRCVGPVU .CUV/QFKƂGF5.

(9) 9. JULY 15, 2019 :: Ophthalmology Times. editorial advisory board. OFFICIAL PUBLICATION SPONSOR OF. MISSION STATEMENT. JULY 15, 2019 ◾ VOL. 44, NO. 12. Ophthalmology Times is a physician-driven media brand that presents cutting-edge advancements and analysis from around the world in surgery, drug therapy, technology, and clinical diagnosis to elevate the delivery of progressive eye health from physician to patient.. Ophthalmology Times’ vision is to be the leading content resource for ophthalmologists. Through its multifaceted content channels, Ophthalmology Times will assist physicians with the tools and knowledge necessary to provide advanced quality patient care in the global world of medicine.. CONTENT Chief Medical Editor Peter J. McDonnell, MD. CHIEF MEDICAL EDITOR Peter J. McDonnell, MD Wilmer Eye Institute Johns Hopkins University. Group Editorial Director Sheryl Stevenson [email protected] 440/891-2625. Baltimore, MD. ASSOCIATE MEDICAL EDITORS. Executive Editor David Hutton [email protected] 440/891-2606. Dimitri Azar, MD University of Illinois, Chicago Chicago, IL. Associate Editor Julianne Mobilian [email protected] 440/891-2608 Senior Graphic Designer Lecia Landis. Anne L. Coleman, MD. Ernest W. Kornmehl, MD. Robert K. Maloney, MD. Jules Stein Eye Institute, UCLA Los Angeles, CA. Harvard & Tufts Universities Boston, MA. Los Angeles, CA. Joan Miller, MD. Randall Olson, MD. Robert Osher, MD. Massachusetts Eye & Ear Infirmary Harvard University Boston, MA. University of Utah Salt Lake City, UT. University of Cincinnati Cincinnati, OH. Graphic Designer Steph Bentz Anterior Segment Techniques Ernest W. Kornmehl, MD. Anterior Segment/Cataract Cornea/External Disease. coding.doc L. Neal Freeman, MD, MBA Money Matters John J. Grande, Traudy F. Grande, and John S. Grande, CFPs® Neuro-Ophthalmology Andrew G. Lee, MD. Ashley Behrens, MD Wilmer Eye Institute, Johns Hopkins University Baltimore, MD. Elizabeth A. Davis, MD. Ophthalmic Heritage Norman B. Medow, MD. University of Minnesota, Minneapolis, MN. Tech Talk H. Jay Wisnicki, MD. Kuldev Singh, MD. Peter S. Hersh, MD. Stanford University Stanford, CA. University of Medicine & Dentistry of New Jersey Newark, NJ. Joshua D. Stein, MD. Jonathan H. Talamo, MD. University of Michigan Ann Arbor, MI. Harvard University Boston, MA. Robert N. Weinreb, MD. Kazuo Tsubota, MD. Hamilton Glaucoma Center University of California, San Diego. Keio University School of Medicine Tokyo, Japan. Uday Devgan, MD. Uveitis Update Emmett T. Cunningham Jr., MD, PhD, MPH. Neuro-Ophthalmology. Jules Stein Eye Institute,UCLA Los Angeles, CA. Richard S. Hoffman, MD. PUBLISHING /A D V E R T I S I N G. Oregon Health & Science University Portland, OR. Stanley Chang, MD. Blanton Eye Institute, Houston Methodist Hospital Houston, TX. Columbia University New York, NY. Oculoplastics/ Reconstructive Surgery. Samuel Masket, MD. Group Publisher Leonardo Avila [email protected] 302/239-5665. Jules Stein Eye Institute,UCLA Los Angeles, CA. Publisher Erin Schlussel Stever [email protected] 215/962-5399. Bartly J. Mondino, MD Jules Stein Eye Institute,UCLA Los Angeles, CA. National Account Manager Cherie Pearson [email protected] 609/636-0172. Mark Packer, MD. Pravin U. Dugel, MD Phoenix, AZ. John T. LiVecchi, MD. Duke University Durham, NC. Sharon Fekrat, MD. University of Florida College of Medicine Gainesville, FL. Michael Raizman, MD. Shannath L. Merbs, MD. Sales Director, Digital Media Don Berman [email protected] 203/523-7013. Ehsan “Ethan” Sadri, MD, FACS. Reprints Licensing and Reuse of Content: Contact our official partner, Wright’s Media, about available usages, license fees, and award seal artwork at [email protected] for more information. Please note that Wright’s Media is the only authorized company that we’ve partnered with for MultiMedia Healthcare materials.. Michael Snyder, MD. Wilmer Eye Institute, Johns Hopkins University Baltimore, MD. Newport Beach, CA. Permissions/International Licensing Jillyn Frommer [email protected] 732/346-3007. Pediatric Ophthalmology. Doheny Eye Institute Los Angeles, CA. Cape Coral, FL. Jennifer Simpson, MD. Carl D. Regillo, MD. University of California, Irvine Irvine, CA. Glaucoma. Wills Eye Institute, Thomas Jefferson University Philadelphia, PA. H. Jay Wisnicki, MD New York Eye & Ear Infirmary, Beth Israel Medical Center, Albert Einstein College of Medicine New York, NY. Practice Management. Case Western Reserve University Cleveland, OH. Uveitis Stanford University Stanford, CA. Medina, OH. Bascom Palmer Eye Institute, University of Miami Miami, FL. Lawrence J. Singerman, MD. Emmett T. Cunningham Jr., MD, PhD. Joseph C. Noreika, MD. Richard K. Parrish II, MD. Frank Weinstock, MD. Chief Medical Editors-Emeritus. Boca Raton, FL. Robert Ritch, MD New York Eye & Ear Infirmary New York, NY. Jack M. Dodick, MD. Refractive Surgery. Joel Schuman, MD. MULT IMEDI A HE A LT HC A R E. Oakland University Rochester, MI. Farrell “Toby” Tyson, MD. University of Toronto Toronto, Canada. Audience Development Manager Kelly Kemper [email protected] 612/253-2039. Tarek S. Hassan, MD. Michael Ip, MD. Neeru Gupta, MD. AUDIENCE DEVELOPMENT. Wills Eye Institute, Thomas Jefferson University Philadelphia, PA. Albert Einstein College of Medicine Bronx, NY. SUNY Upstate Medical University Syracuse, NY. PRODUCTION. Julia Haller, MD. Norman B. Medow, MD. Robert D. Fechtner, MD. Production Director Karen Lenzen [email protected] 218/740-6371. University of Toronto Toronto, Canada. Jules Stein Eye Institute, UCLA Los Angeles, CA. Boulder, CO. Cincinnati Eye Institute Cincinnati, OH. David Chow, MD. Robert Goldberg, MD. Account Manager, Recruitment Advertising Joanna Shippoli [email protected] 440/891-2615. Massachusetts Eye & Ear, Harvard University Boston, MA. Retina/Vitreous. Andrew G. Lee, MD. NYU Langone Medical Center New York, NY. William Culbertson, MD. New York University School of Medicine New York, NY (1976–1996). Bascom Palmer Eye Institute, University of Miami Miami, FL. David R. Guyer, MD New York, NY (1996–2004). President Thomas W. Ehardt Vice President, Content and Strategy Daniel R. Verdon Design Director Robert McGarr. MultiMedia Healthcare LLC provides certain customer contact data (such as customers’ names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Healthcare LLC to make your contact information available to third parties for marketing purposes, simply call toll-free 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer service representative will assist you in removing your name from MultiMedia Healthcare LLC’s lists. Outside the U.S., please phone 218-740-6477. Ophthalmology Times does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. Ophthalmology Times cannot be held responsible for the safekeeping or return of unsolicited articles, manuscripts, photographs, illustrations or other materials. Ophthalmology Times is a member of the Association of Independent Clinical Publications Inc. Library Access Libraries offer online access to current and back issues of Ophthalmology Times through the EBSCO host databases. To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477.. PRINTED IN. U.S.A.. Ophthalmology Times Industry Council Leslie Amodei. Cody McKenzie. Ram Palanki. Julie Speed. Optos Inc., Vice President of Global Product Marketing. Glaukos, Director - U.S. Marketing. Santen, Senior Vice President of Commercial, Americas. Johnson & Johnson Vision, Sr. Director of Marketing Americas, Surgical. Rahim K. Hirji, RPh. Aerie Pharmaceuticals President and Chief Operating Officer. John Saharek. Tracy Valorie. Omeros Corp., Director - Marketing. Neil Levine. Brian O’Neal. Imprimis Pharmaceuticals, Chief Commercial Officer. Regeneron Healthcare Solutions Executive Director, Marketing Ophthalmology. Alcon Laboratories Inc., Head of Marketing - U.S. Erin Schallhorn Carl Zeiss Meditec, Sr. Director, Medical Affairs Surgical and Professional Education. Bausch + Lomb, US Pharmaceuticals and Surgical Valeant Pharmaceuticals North America, LLC Sr. Vice President and General Manager. Tom Mitro. How to Contact Ophthalmology Times Editorial. Subscription Services. Advertising. Production. Millennium Place East 25115 Country Club Blvd. North Olmsted, OH 44070 440/826-2800, FAX: 440/756-5227. Toll-Free: 888/527-7008 or 218/740-6477 FAX: 218/740-6417. 485 Route 1 South Building F, Suite 210, Iselin, NJ 08830-3009 732/596-0276, FAX: 732/596-0003. 131 W. First St. Duluth, MN 55802-2065 800/346-0085 FAX: 218/740-7223, 218/740-6576.

(10) 10. JULY 15, 2019 :: Ophthalmology Times. surgery. Macular OCT assists preop cataract surgery evaluation Study shows routine use may improve patient management, guide procedure planning By Cheryl Guttman Krader; Reviewed by Yishay Weill, MD. esults of a retrospective study support the routine use of macular optical coherence tomography (OCT) for preoperative screening of patients scheduled for cataract surgery, according to Yishay Weill, MD. The research evaluated data from 226 consecutive eyes of 226 patients referred to Shaare Zedek Medical Center, Jerusalem, Israel, for cataract surgery during the last two months of 2017. It found that the macular OCT was normal in 51% of eyes and uninterpretable due to low quality in 9%. However, macular pathology was identified in 40% of the eyes. Importantly, the pathology was overlooked in the referral examination in 51% of the eyes with pathology, and its presence led to a change in management in 14% of patients. “Cataract surgery is now a combined rehabilitative and refractive procedure, and our patients’ expectations are higher than ever,” said Dr. Weill, resident, Department of Ophthalmology, Shaare Zedek Medical Center. Dr. Weill noted that the dilated clinical fundus. R. ‘Preoperative OCT allows better patient management in terms of guiding appropriate surgery planning, timing, modification of consent, patient counseling, and matching patient expectations.’ — Yishay Weill, MD. Dilated clinical fundus examination is currently considered the standard of care for preoperative evaluation of the macula. (Photos courtesy of Yishay Weill, MD). examination is currently considered the standard of care for preoperative evaluation of the macula. “Its limited ability to detect pathology in patients with opaque media is a specific concern in the setting of patients presenting for cataract surgery,” he pointed out. Dr. Weill also explained that overlooked macu-. lar pathologies might lead to suboptimal postoperative results, such as unexpected low BCVA and worsening of baseline macular pathology, and that will in turn could lead to dissatisfied patients. “Preoperative OCT allows better patient management in terms of guiding appropriate surgery Continues on page 12 : OCT.

(11) FDA APPROVED. C-CODE 9048 EFFECTIVE JULY 1.. BIG TIME. INNOVATION. 1. THE FIRST AND ONLY OPHTHALMIC STEROID INSERT. DEXTENZA is an advancement in steroid treatment • Resorbable, so no need for removal2. • Designed to deliver a tapered dose1. • Insert can be removed via saline irrigation or manual expression, if necessary2. • Contains fluorescein for visualization2. • Physicians rated DEXTENZA as easy to insert3*. • No additional components or assembly required2. LEARN MORE AT DEXTENZA.COM INDICATION DEXTENZA is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery.. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. WARNINGS AND PRECAUTIONS Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during treatment. Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. ADVERSE REACTIONS The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (1%); and conjunctival hyperemia (1%). The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%). Please see brief summary of full Prescribing Information on adjacent page.. *73.6% of physicians in Study 1 and 76.4% in Study 2 rated DEXTENZA as easy to insert. References: 1. Sawhney AS et al, inventors; Incept LLC, assignee. US patent 8,409,606 B2. April 2, 2013. 2. DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2018. 3. Walters T et al. J Clin Exp Ophthalmol. 2016;7(4):1-11. © 2019 Ocular Therapeutix, Inc. All rights reserved. DEXTENZA is a registered trademark of Ocular Therapeutix, Inc. PP-US-DX-0071 02/2019.

(12) JULY 15, 2019 :: Ophthalmology Times. BRIEF SUMMARY: Please see the DEXTENZA Package Insert for full prescribing information for DEXTENZA (11/2018) 1. INDICATIONS AND USAGE. DEXTENZA® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery (1). 4. CONTRAINDICATIONS. DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. 5. WARNINGS AND PRECAUTIONS. 5.1 Intraocular Pressure Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. 5.2 Bacterial Infection Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection [see Contraindications (4)]. 5.3 Viral Infections Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex) [see Contraindications (4)]. 5.4 Fungal Infections Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate [see Contraindications (4)]. 5.5 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 6. ADVERSE REACTIONS. The following serious adverse reactions are described elsewhere in the labeling: • Intraocular Pressure Increase [see Warnings and Precautions (5.1)] • Bacterial Infection [see Warnings and Precautions (5.2)] • Viral Infection [see Warnings and Precautions (5.3)] • Fungal Infection [see Warnings and Precautions (5.4)] • Delayed Healing [see Warnings and Precautions (5.5)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and Precautions (5)].. DEXTENZA was studied in three randomized, vehicle-controlled studies (n = 351). The mean age of the population was 68 years (range 43 to 87 years), 62% were female, and 85% were white. Forty-six percent had brown iris color and 31% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (1%); and conjunctival hyperemia (1%).. surgery. The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%). 8. USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations [see Animal Data]. Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m2 basis. In a rabbit study, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is approximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m2 basis. 8.2 Lactation Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however the systemic concentration of dexamethasone following administration of DEXTENZA is low [see Clinical Pharmacology (12.3)]. There is no information regarding the presence of DEXTENZA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production to inform risk of DEXTENZA to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DEXTENZA and any potential adverse effects on the breastfed child from DEXTENZA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. 17 PATIENT COUNSELING INFORMATION Advise patients to consult their surgeon if pain, redness, or itching develops.. MANUFACTURED FOR: Ocular Therapeutix, Inc. Bedford, MA 01730 USA PP-US-DX-0072. (ABOVE) SD-OCT scan showing neovascular AMD with subretinal fluids in a patient scheduled for cataract surgery. The pathology was not detected clinically and was only diagnosed by the preoperative OCT examination.. (RIGHT) Among the most common macular pathologies were epiretinal membrane (27 eyes). (Photos courtesy of Yishay Weill, MD). OCT. generation (43 eyes), epiretinal membranes (27 eyes), and cystoid macular edema (18 eyes). “All patients found to have macu( Continued from page 10) lar pathologies were disqualified as candidates for a multifocal IOL,” said planning, timing, modification of conDr. Weill. sent, patient counseling, and matching In some patients, discovering overpatient expectations,” Dr. Weill said. looked macular pathology using OCT “At our institution, a policy for rouled to a delay in surgery, and an offering tinely performing macof combined surgery ular OCT for screento address the macuing of cataract patients lar pathology and catawas implemented durract, or use of adjunc◗ In a retrospective ing the second half of tive therapy, such as an study, preoperative 2017.” intravitreal injection of macular OCT The 226 patients ina corticosteroid or antiidentified macular cluded in the research VEGF agent. pathology overlooked study had a mean age of D r. We i l l a l s o on fundus 73 years, were predompointed out that preexamination, and inantly female (57%), operative macular OCT the findings led to and were seen by their is easy to implement management changes referring eye care pracbecause it is widely in a large percentage titioner at an average available, non-invaof patients. of 59 days before their sive, and quick. preoperative OCT. However, he conThe macular OCT cluded that the need was performed with a spectral-dofor research to evaluate the cost-efmain system (Spectralis, Heidelberg fectiveness of its routine use for preEngineering). operative evaluation of cataract surAll of the OCT scans were then regery patients. ■ viewed by a retina specialist. Some of the patients found to have YISHAY WEIL, MD macular pathologies had more than E: [email protected] one finding. This article is adopted from a presentation by Dr. Weill at The most common macular patholAAO2018. He has no relevant financial interests to disclose. ogies were age-related macular de-. TAKE-HOME.

(13) JULY 15, 2019 :: Ophthalmology Times. surgery CORTICAL PROSTHESIS ( Continued from page 1 ) Following that initial testing session, patients continued to adapt to the device and were ready to take the device home for use after about 3 months. Six months after implantation, the impact of the implant on patients’ well-being and functional vision was evaluated. Of the five patients with formal evaluation at 6 months, two (40%) of the patients had a significant and three (60%) had a mild improvement in visual function. “Every patient saw some visual perception in response to stimulation at almost every electrode when activated,” Dr. Pouratian said. “Patients described phosphenes of different shapes that appeared as a spot of light, a circle, an oval, or a line.” VISUAL R EHABILITATION Patients work with visual rehabilitation specialists once they begin to use the device at home. “A major step is their learning how to use the device in a meaningful way,” Dr. Pouratian said. “The visual perceptions of these patients who have bare or no light perception are not the same as those of sighted individuals, but we have found that the visual perceptions can be meaningful changes to them.” Some of the subjects can use the device to perform square localization, i.e., the ability to identify a square presented on a screen. When direction-of-motion testing was performed, many were able to Dr. Pouratian identify accurately the direction of movement, he noted. More significant than objective testing, however, is real-world use of the device. For instance, one patient was able to locate a cue ball on a pool table. Another patient described cars that were parked on the side of the street and the direction in which other people on the sidewalk were moving and how the device allowed him to navigate better. Investigators reported the occurrence of five adverse events in two patients, only one of which was serious (seizure). ACCELER ATED DEVELOPMENT With encouraging results from the first six subjects, the company is on a path to accelerated development of the visual cortical prosthesis system, explained Will McGuire, president and chief executive officer of Second Sight. “With five subjects out to the 1-year mark, the company has increasing confidence in the clinical data,” he said. Because the visual cortical prosthesis system can treat more blind patients with different pathologies, the market has the potential to be up to 50 times larger than that with the company’s retinal pros-. The Edward S. Harkness Eye Institute thesis system (Argus II), which treats only retinitis pigmentosa, according to McGuire. Finally, the visual cortical prosthesis system is a more attractive platform, in that its technology and the visual quality and usefulness can be improved more compared with Argus, i.e., the potential use of more electrodes and, thus, many more pixels and the treatability of both brain hemispheres to increase the field of view and visual quality, he noted. To facilitate the accelerated program, Second Sight has a 3- to 5-year plan that is focusing on the organizational structure; adding positions in research and development, quality control, repertory affairs, and clinical research; and making changes in the supply chain and manufacturing capabilities. Technologic improvements envisioned by McGuire for the visual cortical prosthesis system include electronics enhancements so that many more electrodes can be used, i.e., a 169-channel chip compared with the current 60. Other complementary technologies to artificial vision being pursued by Second Sight are object and facial recognition software, which will inform the user of what or who is the viewed object, and infrared imaging, in which the stimulated vision is produced by heat to facilitate locations of objects. McGuire is hopeful about reimbursements by the Centers for Medicare and Medicaid Services (CMS) as a result of the Breakthrough Device designation and the potential for an add-on automatic payment by CMS for 2 years with the designation. WHAT ABOUT ARGUS II? Second Sight Medical Products remains committed to supporting existing Argus II users including pursuing regulatory approvals for the Argus IIs nextgeneration externals, according to McGuire. “We have next-generation externals, Argus IIs, under development that include new eyewear, camera, and more powerful VPU to upgrade the current patients,” he said. “We will supply eyewear and VPU replacements as needed. “Personnel will be available to evaluate the technology and provide changes to the settings to optimize the vision as it changes over time,” he said, and forecasts the new externals to be available before the end of 2019. ■. NADER POURATIAN, MD, PHD E: [email protected] Dr. Pouratian is a consultant to Second Sight Medical Products. JESSY D. DORN, PHD E: [email protected] Dr. Dorn is an employee of Second Sight Medical Products. ROBERT GREENBERG, MD, PHD Dr. Greenberg is a consultant to Second Sight Medical Products.. PRECISION OPHTHALMOLOGY 2020. APPLYING GENETICS TO EYE CARE TODAY Program Chairs: Irene Maumenee, MD Stephen H. Tsang, MD, PhD. Save the Date December 6, 2019 The University Club 1 West 54th Street New York City Columbiaeye.org/ Precision2020 This activity has been approved for AMA PRA Category 1 Credit™. Columbia University Department of Ophthalmology.

(14) JULY 15, 2019 :: Ophthalmology Times. 14. surgery. Laser therapy maintains position as key DME treatment option Amid introduction of new technologies, device still playing critical role By Lynda Charters; Reviewed by Elias Reichel, MD. LASER REMAINS A critical component in the treatment of diabetic macular edema (DME) amid an increasing number of new devices designed to deliver subthreshold laser. “Laser still plays a very important role in the treatment of diabetic macular edema despite our reliance on antivascular endothelial drugs,” said Elias Reichel, MD, professor of ophthalmology and vice chairman, Tufts University School of Medicine, Boston. The Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol I study supports that statement, with patients treated with deferred laser therapy, defined as application between 24 weeks, fared the best. Over the course of two years, Dr. Reichel pointed out, there was a benefit in those patients compared with those treated promptly with laser, and accompanied by antiVEGF or steroid therapy and sham treatment. As an additive therapy, laser is helpful even in DRCR.net Protocol T compared to primary VEGF therapy. Subthreshold laser is defined as that which shows no signs of damage to the clinical examiner, Dr. Reichel explained, and demonstrated what constitutes subthreshold laser therapy. In a patient with 20/50 visual acuity (VA), fluorescein angiography (FA) showed difA patient with diabetic macular edema with vision at 20/100 is a primary candidate for laser. (Photos courtesy of Elias Reichel, MD) fuse leakage through the macula, and optical coherence tomography (OCT) showed the cystic change. The patient the clinical efficacy is supported only The devices approved in the United was treated with microFour months after by limited case series, which provided St ate s a l l u se ye l low or g re en pulse laser in the left eye laser treatment, the VA data on Micropulse and Endpoint Manwavelengths. with the setting of 400 was 20/30. No changes ◗ Laser continues to agement (Topcon Medical Systems, Three micropulse devices have been mW, 200 μm spot size, resulting from the treatInc.), he commented. The usefulness approved. They include Micropulse (IRIfor 200 ms; 343 spots ment or pigmentary play an important role of laser demonstrated in the DRCR.net DEX), Quantel Laser (SubLuminal), and were applied, which is changes were visible in diabetic macular concerned conventional laser photocoLumenis (SmartPulse). seven applications on a on fluorescein angiogedema amid an agulation only. Topcon makes continuous-wave 7 x 7 grid. An important raphy. The foveal apincreasing reliance on “It is important to understand that technology (Endpoint Management). factor in this treatment pearance on OCT was anti-VEGF drugs. micropulse therapy can be applied to Ellex manufactures Retinal Rejuvenawas the 5% duty cycle, more normal than bethe fovea in patients with DME, but tion Therapy (2RT), a microbubble diswhich has been able to fore treatment with Endpoint Management and microbubble ruption therapy. perform subthreshold laser treatment some small central cysts visible. disruption avoids the fovea,” he said. Compared with conventional laser— safely even with application to the fovea, All of the basic science research has FDA A PPROV ED DEV ICES Continues on page 16 : Laser he emphasized. supported subthreshold laser; however,. TAKE-HOME.

(15) Let Us Be Your Eyes and Ears. Introducing EyePod: Podcasts from Ophthalmology Times This new audible resource from Ophthalmology Times engages with key opinion leaders in interviews about the latest innovations in the areas of surgery, clinical diagnosis, pharmaceutical advancements, research, and technology, plus practice management.. Hear the voices of ophthalmic innovation. OphthalmologyTimes.com/EyePod.

(16) INNOVATION IN SIGHT Novartis is an industry leader in reimagining medicine.. OVER 4 MILLION US prescriptions filled in 2018. Visit us at ASRS!. Find Novartis at booth #512 and learn more about our commitment to retina.. Reference: Data on file. Novartis Pharmaceuticals Corp; 2019.. Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080. © 2019 Novartis. 6/19. HRT-1376783.

(17) JULY 15, 2019 :: Ophthalmology Times. 16. surgery. Setting expectations for glaucoma patients having cataract surgery Pearls can ensure physicians get best outcomes, help patients set realistic goals By Vanessa Caceres; Reviewed by Anup Khatana, MD. SETTING EXPECTATIONS FOR patients. formed first or do a combined procedure. and physicians before cataract surgery in advanced “Cataract surgery after a filtering procedure may glaucoma cases was one of eight pearls shared by pose a risk to the bleb, but combined surgery also Yvonne Ou, MD, associate profesmay make some parts of surgery easier,” Dr. Ou said. sor of ophthalmology and co-diOne option is performing cataract surgery alone, rector of the glaucoma service, Dewhile another pre-surgical plan involves IOL selection. partment of Ophthalmology, UCSF, “Most of us will choose a monofocal IOL, but San Francisco. Dr. Ou focused her it’s also worthwhile to consider a toric,” she said. pearls on advanced glaucoma paThere is research that shows greater astigmatic tients having catacorrection and good visual outcomes ract surgery. with the use of toric IOLs in this paDr. Ou “All of us know tient group, but be careful with this many of these tips, but taken tochoice in patients who have pseudo◗ With planning gether, they can help minimize viexfoliation, Dr. Ou cautioned. and strategic use sion loss,” she said. Dr. Ou also noted that physicians of surgical tips and Here are Dr. Ou’s eight pearls: should avoid multifocal IOLs in adtechniques, physicians vanced glaucoma patients. can lower the chance 1. USE C A R EFUL for vision loss in 2 . M A NAGE E X PE C TAT ION S SURGICAL PLANNING advanced glaucoma Part of this planning process is Physicians also should consider conpatients having deciding whether to do a staged prosenting for cataract surgery with or cataract surgery. cedure with glaucoma surgery perwithout bleb revision.. TAKE-HOME. LASER ( Continued from page 14 ). characterized by a solid block of laser application over time (100 or 200 ms) accompanied by a temperature increase—the heat produced is absorbed by the retinal pigment epithelium (RPE) and choriocapillaris and is in turn diffused into the neurosensory retina with the potential to cause damage. Micropulse therapy is a packet of energy that is delivered over 200 ms; the laser is on 5% of the time and off 95% of the time in the individual packets. “There is an increase in temperature; the retinal tissue heat, but they cool rapidly, and there is no diffusion damage to the neurosensory retina,” Dr. Reichel said. According to Dr. Reichel, Endpoint Management differs from Micropulse because it relies on the Arrhenius integral and describes the changes in temperature in time and space over biologic tissues in response to laser energy. “This technology uses a short-pulse duration. within a narrow therapeutic window and the biologic damage is proportional to the laser power,” he explained. The algorithm that is used in this technology results in a spot that shows barely visible damage. The power setting then drops 70% to reach the perfect level of treatment energy and duration for surgeons to use. Dr. Reichel provided an example in with the energy level was about 30% for 12 ms. Microbubble disruption provides selective targeting of individual RPE cells. The microbubbles around the melanosomes expand, causing intracellular damage resulting in individual cell apoptosis. The adjacent RPE cells migrate, divide, and produce new RPE cells. Dr. Reichel commented that there are no landmark burns in these technologies except for the those produced by the algorithm used in Endpoint Management. The others rely on physician titration, which necessitates that they observe retinal burns. PR ACTICA L TIPS. “Patients with well-controlled or low IOP are less likely to have an IOP drop,” Dr. Ou said. 3 . TA K E S T E P S PR O PH Y L AC T IC A L LY T O AV O I D A N I O P S P I K E Patients with a longer axial length, prior laser trabeculoplasty, or who used a larger number of medications were more likely to have a spike in previous research, Dr. Ou reported. Oral acetazolamide, Miostat, and a topical beta blocker or a combination drop of beta blocker and carbonic anhydrase inhibitor all are options to help protect against IOP spikes. 4. MINIMIZE INFLAMMATION “Use all the methods at your disposal for a nice, dilated pupil,” Dr. Ou advised. Efforts to minimize inflammation could include visco dilation with Healon5 or several other iris expansion techniques. Thorough cortex removal also is important. Continues on page 18 : Glaucoma. According to Dr. Reichel, physicians use the correct preset, confirm the correct treatment mode and make sure the laser is not set to the conventional treatment mode. They also should confirm the 5% duty cycle setting when using Micropulse, and be aware of landmarks and placement of treatment spots. “Several different subthreshold technologies are available,” he said. However, Dr. Reichel noted that the administration of subfoveal therapy is only possible with Micropulse. “The ability to perform Micropulse and the recommended titration and the appropriate protocol and settings should be confirmed with the manufacturer,” he concluded. “No clinical trials have been conducted to confirm the superiority or noninferiority of Micropulse to conventional laser with any of the subthreshold technologies.” ■. ELIAS REICHEL, MD E: [email protected] Dr. Reichel is a consultant to Lutronics, a member of the speakers’ bureau for IRIDEX, and received a research grant from Lumenis..

(18) nurture T H E I R EY ES Take a fresh approach to treating dry eye symptoms with FRESHKOTE® Preservative Free (PF) Patented polymer blend of polyvinyl alcohol and povidone supports all layers of the tear film1,2 Triple-acting formula reduces evaporation and increases stability of the tear film while high oncotic pressure draws excess water from epithelial cells1,3 Compatible for use with contact lenses4 State-of-the-art multidose bottle provides more than a month’s worth of preservative-free drops when dosed 4 times a day5. R EC O M M E N D S O OT H I N G R E L I E F Visit. FRESHKOTEPF.com to learn more. References: 1. Holly FJ. Lacrophilic ophthalmic demulcents. US Ophthalmic Rev. 2007;3:38-41. 2. FRESHKOTE Drug Facts. Eyevance Pharmaceuticals LLC; 2018. 3. Holly FJ. Colloidal Osmosis — Oncotic Pressure. Grapevine, TX: Dry Eye Institute; 2006. 4. Fuller DG, Connor CG. Safety and efficacy of FreshKote® used as a rewetting agent in Lotrafilcon-A® contact lens wearers. Poster presented at: American Academy of Optometry Annual Meeting; November 17-20, 2010; San Francisco, CA. 5. Nemera. Novelia®. https://nemera.net/products/ophthalmic-novelia-eyedropper/. Accessed March 14, 2019. © 2019 Eyevance Pharmaceuticals LLC. All rights reserved. FRESHKOTE® is a registered trademark of Eyevance Pharmaceuticals LLC. Novelia® is a registered trademark of Nemera Development. FPF-19-AD-05.00.

(19) JULY 15, 2019 :: Ophthalmology Times. 18. surgery. Hypotony more than just a number; consider symptoms during therapy While numerous techniques are available to surgeons, awareness is important By Lynda Charters; Reviewed by Eydie G. Miller-Ellis, MD. HYPOTONY, LOW IOP after surgery, can have an adverse impact on a patient’s vision. It is defined as an IOP of 5 mm Hg or less and generally occurs in the early postoperative timeframe, during periods of overfiltration. It can last for a few weeks. Chronic hypotony, while not uncommon, is another ball of wax because it can persist for longer than three months postoperatively. The Tube versus Trabeculectomy Study found that about 13.5% of patients had chronic hypotony, but only about half experienced associated adverse effects, according to Eydie G. Miller-Ellis, MD, chief, Glaucoma Service, and professor of Clinical Ophthalmology, Scheie Eye Institute, University of Pennsylvania Perelman School of Medicine, Philadelphia. Numerous techniques are available to avoid chronic hypotony, but Dr. Miller-Ellis noted that awareness of the condition is important. “We are concerned with choroidal expansion, which occurs when the IOP is lower than the intravascular pressure, and there is an elevated risk of choroidal detachment, hypotony maculopathy, and other associated complications,” she pointed out. Not everyone has adverse effects as the result of an IOP below 5 mm Hg. Some patients can feel well in that scenario. On the flip side, clinical hypotony is the scenario in which a patient with low IOP experiences associated visual or ocular side effects, Dr. Miller-Ellis explained.. MONITORING IOP When patients have progressive disease at IOPs of 12 or 15 mm Hg, clinicians want to establish an IOP at a level low enough to decrease the stress on the lamina and the retinal nerve fibers to preserve the. vision and possibly improve the blood flow. However, while the not-too-low IOP value makes the clinician happy, he or she has to be concerned about how the patient is feeling and rule out any associated complications. The signs associated with choroidal expansion— shallowing of the anterior chamber, choroidal detachment, choroidal hemorrhage, long-term hypotony maculopathy—are issues. “The bigger concerns, even in patients who do not have visible choroidal detachments or hypotony maculopathy, are that they can have blurred fluctuating vision and some ocular discomfort,” Dr. Miller-Ellis said. “When the IOP is low, the globe can become. R ISK FACTORS One complication, hypotony maculopathy, tends to develop more often in association with male gender, younger age, myopia, after a primary filtering surgery, in a phakic patient, and in Caucasians. Choroidal detachments tend to occur more often in older patients and shorter eyes, Dr. Miller-Ellis explained.. GLAUCOMA. viscoelastic material and is available on the website CataractCoach.com, Dr. Ou said.. ( Continued from page 16 ). 6 . PR OT E C T A N D/OR R E V I V E Avoid manipulation of the bleb, and consider adding a 5-fluorouracil injection at the end of the case and during postoperative visits. To get a sense of bleb function intraoperatively, trypan blue can be used but is not always predictive, Dr. Ou said.. 8. CONSIDER USE OF STEROIDS The use of ophthalmic steroids are especially key if the surgeon sees early indications of bleb failure, Dr. Ou explained. Ophthalmic steroids, usually eye drops, gels, or ointments, are made to be administered in or around the eye. They also treat inflammation and relieve symptoms that can include pain, swelling, irrigation and redness. ■. 7. M A I N T A I N C L O S E F O L L OW  U P Spikes in IOP can occur four to six hours after surgery, so consider same-day postoperative visits for at-risk patients or a close follow-up to monitor for IOP spikes.. YVONNE OU, MD E: [email protected] This article was adapted from Dr. Ou’s presentation at the American Glaucoma Society annual meeting. Dr. Ou is a consultant for Merck.. 5 . R E MOV E V I S C OE L A ST IC M AT E R I A L Viscoelastic is necessary to maintain the anterior chamber depth throughout the procedure, especially in hyperopic eyes and those with prior filtering surgery. Complete removal can be a challenge, but take the extra time to do it, especially in high myopes, Dr. Ou said. Make sure to also remove viscoelastic material behind the IOL. A technique from Uday Devgan, MD, called angle sweep shows a way to help remove. deformed with every blink or eye rubbing and they develop visual symptoms based on that.” Hypotony resulting from a big bleb can also cause bleb dysesthesia—dry eye or tear film disruption— which is even more problematic for many patients.. ‘When the IOP is low, the globe can become deformed with every blink or eye rubbing and they develop visual symptoms based on that.’ — Eydie Miller-Ellis, MD. CASES Dr. Miller-Ellis described a representative case of a 54-year-old Caucasian man with pigmentary glaucoma, 4.0 diopters of myopia, and a corneal thickness of 520 μm. Continues on page 19 : Hypotony.

(20) JULY 15, 2019 :: Ophthalmology Times. 19. surgery HYPOTONY. ‘Even without choroidal detachments or hypotony maculopathy, we must focus on the patients’ symptoms.’ — Eydie Miller-Ellis, MD. ( Continued from page 18 ). The patient underwent bilateral trabeculectomies with mitomycin C in 2005 and 2006. The IOP remained under control until 2013, when it began to increase to the upper teens in one eye. The IOP increase was reThe third case was that of an 80-yearfractory to medical therapy. Bleb needling old African-American woman who underresulted in an IOP of 1 mm Hg. Months after went a phaco-trabeculectomy and had an the needling, the IOP remained low, between initial IOP of 4 mm Hg with a shallow an2 and 3 mm Hg. terior chamber. The patient’s vision was By six weeks postopera“quite good,” (20/25) withtively, the IOP remained low out choroidal effusions or hybut the anterior chamber had ◗ Managing hypotony potony maculopathy despite deepened and at six months is not based on the the patient reporting some vipostoperatively the IOP was intraocular pressure sual fluctuations and slightly 5 mm Hg. The outcome was alone. Symptoms are less ocular comfort than the good, with 20/25 vision, no a big consideration fellow eye that were not probchoroidal expansion, and a and must be lematic for him. deep anterior chamber. accounted for during A second case was that of a The last case was that of a treatment. 70-year-old Caucasian woman 69-year-old Caucasian woman who had undergone trabecuwho underwent a trabeculectomy with mitomycin C in lectomy with mitomycin C the right eye four years earlier. The IOP in 13 years earlier. that eye was 8 mm Hg. The vision was 20/20 The bilateral IOPs were 4 mm Hg, but and the visual field was stable. There was she complained of poor vision with acuno evidence of dellen. Despite the excellent ities of 20/80 and 20/25 in the right and clinical picture, the patient was extremely left eyes, respectively, with mild cataracts. uncomfortable as a result of a persistent forThe refraction was moderate myopia with eign body sensation. a corneal thickness of 510 μm. The patient The patient had been referred for surgery had turned down bleb revision surgeries on in the other eye, but she refused because of multiple occasions. the status of the right eye. Dr. Miller-Ellis recounted that the patient “Even if the corneal surface is good and had significant bilateral hypotony maculopthere is no evident choroidal expansion, treatathy with folds extending through the macing the surface disease is necessary to increase ula to the periphery. the patient’s comfort before another intervenOver time, the vision has deteriorated tion is considered,” Dr. Miller-Ellis explained. further because of the cataracts. However, there is little chance of the vision returning to normal with IOP normalization since the maculopathy is longstanding, but cataract surgery might provide some improvement. When you consider how low the IOP can go, Dr. Miller-Ellis noted that the ideal goal Find us on all of these platforms might be between 8 to 12 mm Hg because Join the discussion at you can maximize the protective effect of Facebook.com/ the IOP and maintain functional vision. OphthalmologyTimes “Even without choroidal detachments or hypotony maculopathy, we must focus on the Follow us @OphthTimes patients’ symptoms,” she concluded. “They need to feel well in order to accept that the See more images at surgery has been successful for them. While Instagram.com/ risk factors can be identified in our patients, OphthalmologyTimes they are individuals and can be unpredictListen to full interviews at able.” ■ Soundcloud.com/ OphthalmologyTimes. TAKE-HOME. FOR MORE FROM OPHTHALMOLOGY TIMES. Watch more surgical procedures and pearls at YouTube.com/OphthalmologyTimes. EYDIE G. MILLER-ELLIS, MD E: [email protected] Dr. Miller-Ellis has no financial interest in any aspect of this report..